FDA.reportPublic FDA data

MAUDE MDR 3443998

MDR report key
3443998
Report number
1628664-2013-00300
Event key
0
Event type
3
Date received
2013-11-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
Phone
847-847-8479
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCHITECT C16000 SYSTEMABBOTT MANUFACTURING INCMZV03L77-01N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-11-010

Event Narratives#

D

Patient 1

THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A FALSELY ELEVATED POTASSIUM ASSAY RESULT ON THE ARCHITECT C16000 ANALYZER. AN INITIAL RESULT OF 6.3 MMOL/L RETESTED AT 4.7 AND 4.6 MMOL/L. NO SUSPECT RESULTS HAD BEEN REPORTED FROM THE LAB WITH NO PATIENT IMPACT.

N

Patient 1

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).